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Re: Number sleven post# 438334

Wednesday, 08/27/2025 2:54:21 PM

Wednesday, August 27, 2025 2:54:21 PM

Post# of 447446
Sleven, I agree with those points. When this topic was raised a few months ago (or at some point, I don't recall), someone here indicated that the FDA would not accept Japanese study data. This is why I felt that a short safety trial would be required.

It would be fantastic if the FDA did accept that trial data. I just don't have enough knowledge to determine whether that would be the case or not.

But I have zero concerns about safety. Just trying to look forward at potential timelines that Amarin may be looking at.
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